At the heart of the development of medical devices and in vitro diagnostics, Amarok Biotechnologies’ Performance Evaluation Laboratory (LEP) plays a key role in ensuring the conformity and performance of the automata and methods used by clinical laboratories. Ludovic Chaillet, engineer at LEP, and Alexandre Rivoallan, reference technician, share their expertise on the evaluation process and explain why manufacturers call on Amarok Biotechnologies to validate their products.
Could you describe the main activities of Amarok Biotechnologies’ LEP?
Ludovic Chaillet: Amarok Biotechnologies’ LEP specializes in the evaluation of medical devices, in particular automated devices and in vitro diagnostic methods. We carry out studies to guarantee the conformity and performance of devices before they are put on the market, or to maintain their conformity. We work closely with manufacturers to generate the data required for regulatory submission, following rigorous protocols for each evaluation.
What types of customers use your services, and how do you support them?
Ludovic Chaillet: Our customers are mainly manufacturers of automated systems and medical analysis methods. Among them, we have for several years been supporting French companies such as Stago, a leader in the field of blood coagulation, and Diagast for immuno-hematology, throughout the evaluation process to ensure that their products meet regulatory requirements and performance updates in line with IVDR and other standards.
How does Amarok’s LEP validation and results verification process work?
Ludovic Chaillet: Our evaluation process follows a rigorous protocol based on international standards to guarantee the quality and conformity of results at every stage. It all starts with validation of the specifications by the customer, who also approves the methodologies before the study begins.
During the course of the study, results are systematically recorded both on paper and electronically. To guarantee exact correspondence between electronic data and paper documents, a double check is carried out by two different people. This procedure ensures optimum accuracy in data processing. Finally, a random sampling of results is taken for final verification.
At the end, all results are scanned and sent to the customer. The customer then receives all the documents needed to prove that the work has been carried out to the highest standards.
What quality standards do you adhere to at LEP?
Ludovic Chaillet: We have just renewed our ISO 17025:2017 accreditation with an extension to blood group immunohematology. This attests to our ability to carry out tests in line with the highest quality standards. We also comply with international standards such as those of the Clinical Laboratory Standards Institute (CLSI), to ensure that each automaton or method is rigorously evaluated. This accreditation and these standards enable us to deliver reliable results recognized by regulatory authorities in Europe, the USA and China.
How do you ensure confidentiality of data and results for your customers?
Alexandre Rivoallan: Confidentiality is at the heart of our operations. All the data we handle is secured and stored in such a way as to protect sensitive information. We undertake not to divulge any information concerning the studies we carry out, either about the products or the methods tested. We work only with the data required for the study, and adhere to strict confidentiality protocols to ensure total discretion vis-à-vis our customers.
What sets Amarok Biotechnologies’ LEP apart from other laboratories?
Alexandre Rivoallan: What sets us apart is our independence, impartiality and specific expertise in performance evaluation. Unlike other laboratories that carry out clinical tests, we are not consumers of products, but offer a complete evaluation of their automata and methods. We are one of the very first laboratories in France to be ISO 17025 accredited for this particular activity. This guarantees that our assessments are internationally recognized and respected. We provide manufacturers with reliable results that comply with the most stringent standards, such as those of the CLSI and European bodies.
What are the future plans for Amarok Biotechnologies’ LEP?
Ludovic Chaillet: We have a number of projects underway, including a move to larger premises that will enable us to increase our capacity to receive and process studies. We are also planning to expand our range of services by obtaining additional accreditations. Our aim is to become a European reference laboratory for blood grouping devices, which will strengthen our market position.
In conclusion, Amarok Biotechnologies’ LEP is a key player in the evaluation of medical devices, thanks to its expertise, impartiality and commitment to quality. If you are a manufacturer wishing to validate your products with a trusted partner, or a professional motivated by the challenges of medical innovation, please do not hesitate to contact us.